COMPLAINTS

AND RECALLS
PRESENTED BY,
HANDLING.
HUSNA KANWAL QURESHI.
M.Pharm, 1st yr, 2nd sem.
UNDER THE GUIDANCE OF
Dr. T. MAMATHA M.Pharm,
Ph.D.
QUALITY ASSURANCE.
1

COMPLAINT HANDLING
DEFINATION OF COMPLAINT:
Complaint is defined as statement
that is something wrong or not good
enough, which shows customer
dissatisfaction about the company
and the product.
Example: Complaint about packaging
materials, Concerning about the
product etc.
2

NEED FOR COMPLAINT

HANDLING SYSTEM
It gives the company an opportunity
to improve the quality of the product
It is helpful to maintain cGMP
It maintains committed relationship
between the customer and company
It is the regulatory obligation.

SOP on complaint handling

OBJECTIVE: To lay out the procedure for
investigation and reporting the market complaints.
RESPONSIBILITY: The quality assurance manager
along with manager of the complaint related
department.
PROCEDURE:

Complaints shall be classified in following

categories to facilitate investigation:
Product quality complaints (non therapeutic).
Packaging complaints (shortages and packaging
error).
Medical complaints (therapeutic problems).
4

Time period for investigation after receipt of

complaints:
Product quality complaints within 5 days.
Packaging and quality complaints within
10 days.
Medical complaint within 3 days.
Complaint records shall be maintained at
least one year after expiration date of
medicines.
Complaint records shall be reviewed and a
monthly summary shall be prepared for
the management.
6

PRODUCT NAME

COMPLAINT
CATEGORY

Batch no. Mfg.date expiry Packaging/ product quality/

date
medical.
Packaging details:
Name / address of the
complainant:
Complaint
reported
through:
Complainant
sample Total quantity involved
enclosed: yes / no
Quality
of
sample
PCR received by
enclosed:
Investigation report
On:
Investigation done by:
Action taken

Conclusion:
Confirmed/not confirmed

Product complaint data

sheet

Product complaint data sheet should

have the following details:

Serial number assigned to the complaints.

Exact nature of the complaints.
Name of the complainants.
Address of the complainants.
Date of complaint received.
If verbal, name of the person who received
the complaint.
Name of the product, strength and batch
number of the product.
Reference to analytical record number.
8

Quantity involved in the complaint.

Size of sample obtained from the complainant.
Evaluation of complaint by QC department.
Materials and records used to perform
evaluation.
Other possible effected materials, products
and results of their investigation.
Name and signature of the investigator(s) and
date.
Action taken by the company.
Copy of reply sent to complainant.
9

Steps in handling of
complaints
The proposed handling system is in
compliance with the GMP Guidelines of
EU, USA and Brazil and is presented in
four steps:
1.Receiving complaints.
2.Technical investigation.
3.Corrective actions/feedback to
Customers.
4. Monthly reports/trend analysis.
10

Receiving complaints
It is important to have open channels with
with customers in order to receive their
suggestions, doubts and complaints.
Generally, these channels are toll-free
numbers, e-mails, chat-rooms and P.O.
boxes.
The most flexible channels are toll-free
numbers and chat-rooms.
A person must be appointed in charge of
receiving complaints and inputting them
into appropriate investigation form that
shall be addressed.
11

 The investigation form must include:

Information about the complainant:
- Name
- Address
- phone no.
- E mail
Information about the drug product
- Product name
- Lot no
- MFG & Exp date
- Amount of the product with the
problem.
- Detailed description of the complaint.
12

custome
r

Company's
contact
person

QA
complaint
officer

Make a complaint
through toll free no.,
E-mails, P.O. Box

Open the investigation,

including information about
the customer and about the
complaint(product name, lot
no., mfg & expiry date and
complaint description.)
Ask the customer to return
the product for analysis.
13

Technical investigation
Upon receipt of the investigation form, the QA unit is
able to start the investigation.
It is divided into two phases:
Documentation based investigation.
Laboratory analysis.
Documentation based investigation:
The primary documentation to be reviewed consists
of:
Complaint files: This is constituted to check how
many other complaints of the same nature had
occurred to a specific lot and how they were handled.
Batch records must be verified in order to see if there
were any non-conformance during the production.
14

Laboratory analysis phase

It consists of requesting the Quality Control
(QC) laboratory to analyze.
Complaint samples.
Retained samples.
Complaint samples are the customer sample.
Retained samples the reserve samples
representative of the lot manufactured (which
were kept under appropriate conditions of
temperature, humidity and light so that the
drug product was not affected).
The company elects a person in the QA unit to
be in charge of technical investigation of each
complaint, e.g. a Complaint Officer.

15

Documentation
based
Check complaint
files for previous
complaints of same
nature.
Check batch
records.

16

 There are three possible conclusions, as follows:

Confirmed complaints.
Non confirmed complaints.
Counterfeit/ tamper suspicion.

CONFIRMED COMPLAINTS:
When both complaint and retained samples showed
out-of-specification (OOS) results or when only the
complaint sample showed OOS results.
Example:
a single unexplained failure may be when one
tablet is missing in the intact blister strip in the
complaint sample, but no deviation was found in
the retained samples or during the in-process
controls and final QC analysis recorded in the batch
record.
17

NON-CONFIRMED COMPLAINTS:
When both complaint and retained samples
showed results in compliance with specifications
or when only the complaint sample showed OOS
results.
OOS results in a complaint sample can be
attributed to misuse or mishandling, when the
drug product was not kept under appropriate
conditions of temperature, humidity and light so
that the identity, strength, quality and purity of
the drug product could be affected.
Example:
Tablets of the complaint sample show a change
in their appearance that is characteristic of a light,
humidity or high temperature exposure.
18

COUNTERFEIT / TAMPER SUSPICION:

When the retained sample is within the
specification but the complaint sample is
clearly OOS with no reason for that, such
as a counterfeit or tampered drug product.
Example:
when packaging material is different from
the original; an example of tampering is
when the color of the drug product is
completely different from the original or
when any foreign substance was added to
the product.
19

The Complaint Officer must also check if

the complaint represents a serious and
unexpected adverse drug experience.
The Complaint Officer and the QA
Manager must sign off the investigation
form once the investigation is
completed.
30 days is a reasonable time to conclude
an investigation.
Complaint files should be retained for at
least 1 year after the expiry date of the
lot.
20

CORRECTIVE ACTIONS AND

FEEDBACK TO CUSTOMERS
For all confirmed complaints, corrective actions must
be implemented. These actions can range from a
simple and quick training to some employees to a
formal Corrective Action and Preventive Action (CAPA)
handling.
If a CAPA is opened, a multidisciplinary team consisting
of representatives of QA, QC, Regulatory Affairs and
Production Management must be established.
Concerning non-confirmed complaints originating from
misuse or inadequate handling of the drug product.
The customer should receive a written response
together with scientific information on the correct use
and handling.
Contd

21

As feedback to the customer, the

company must write a response letter to
the complainant to explain the
investigation approach taken, the results
obtained and any implications, in case
the quality problem was confirmed.
The customer should be sent a free
replacement product together with the
response letter, since the customer
returned the product (the complaint
sample) to the company for analysis
and a quality problem was found.
22

23

MONTHLY REPORTS AND

TREND ANALYSIS
Monthly reports should be elaborated in order to
evaluate the amount and the nature of the complaints
received and to perform a trend analysis of these
complaints.
The monthly reports must answer the following questions:
How many complaints did the company receive in the
period?
How many were confirmed?
How many were non-confirmed or were
counterfeit/tamper suspicion?
Graphic methods of displaying data are important
adjuncts to data analysis and presentation.
The report must be readily available mainly during GMP
inspections.

24

Documentation final product

complaint report

Nature of the complaint-------------------------Date-----------------Complaint:------------------------Originator of the complaint & title ---------------------------Distribution contact person & title ---------------------------Method of notification---------------------------Name-----------------------------------------------------Phone No.-----------------------------P.O#-------Date shipped-------------Invoice#------Product name:----------------Control no:---------EXP date:---------------- Quantity involved---------------------

25

Total quantity shipped---------------------------------------Reason for complaint return request-------------------------Complaint#------------ Product-------------------Evaluation of complaints:

1.Physical
characteristics------------------------2.Sign of deterioration
---------------------------3.Other
observation------------------------------- Quality control Findings:
1.Returned sample-------------------------2.Returned sample re assay--------------3. initial data------------------------------------26

 4.Quality control comments & suggestions

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- Quality control-------------------,Date------------------- Complaint#____________________________________
Product_______________________________________
Packaging/Labeling/Inserts
evaluation__________________________________________
____________________________________________________
_________________________________
Remarks____________________________________________
_______________________________________
27

Resultant action taken:

1.Method,Date of customer notification &

authorized
action_________________________________________
____________________________________________
2.Comments___________________________________
_______________________________________________
___________________________________________

3.Completion date for action taken

_______________

4.Quality assurance evaluation

_______________________________________________
_______________________________________________
_________________________________
28

Customer complaint record

book

Repo Date
rt no. recei
ved

Produ Recei Produ Date

ct
ved
ct lot inves
name by
no.
tigati
on
start
ed

Date
inves
tigati
on
ende
d

29

RECALL HANDLING
Recall means a firms removal or correction of a
marketed product that the Food and Drug Administration
considers to be in violation of the laws it administers and
against which the agency would initiate legal action, e.g.,
seizure.

The main objectives of this recall plan are:

Stop the distribution and sale of the affected product.
Effectively notify Management, customers and regulatory
authority.
Efficiently remove the affected product from the
marketplace, warehouse and/or distribution areas.
Dispose and Conduct a root cause analysis and report the
effectiveness and outcome of the recall.
Implement a corrective action plan to prevent another
recall.
30

SOP on recall
RESPONSIBILITY:
General manager / vice president: (QA/QC, Regulatory)
General Manager: manufacturing.
In case of adverse event a committee evaluates the
crisis. It consists of following individuals:
GM/V.P/QA/QC, Regulatory
GM Manufacturing
GM, Formulation and Development
Medical advisor
Vice president - Marketing
Vice president International Marketing
Vice president Technical Operations
31

PROCEDURE:
Any employee becoming aware of such medicine
should immediately notify to higher authorities.
Immediately quarantine existing in-house of relevant
medicine. Record the following information:
a) The product name, strength, packs size, batch no., mfg
and expiry date.
b) The total number of units released for sale.
c) Date on which distribution commenced.
d) Total number of units distributed.
e) Number of units still in stock.
f) Nature of reported violation.
In the light of above information higher officials
evaluates the health hazard presented by the violation
medicine and documents it on medicine recall
control document.
32

INDIAN PHARMACEUTICALS LIMITED

Medicine recall control document

Product information:
1. Manufacturer --------------------------------------------------------------2. Product name--------------------------------------------------------------3. Strength----------------------------------------------------------------------4. Pack size-------------------------------------------------------------------5. batch number --------------------------------------------------------------6. total number of units originally released for sale: _________
7. Date of which distribution commenced: ______________
8. Total number of units distributed: _____________________
9. Number of units still in stock:
At factory
With stockiest (s)
10. The nature of the reported violation:
__________________________________________________
33

 Formulating a proposed recall strategy. It specifies the

nature of communication to be used (phone, fax,
telegram, letters, telemail, etc) as well as the level in
the distribution chain to which recall is extended.
(wholesalers, retailers, public, etc).
Relevant records shall be submitted to regulatory
authorities with proposed plan of action.
INDIAN PHARMACEUTICALS LIMITED
Medicine recall control document
3. RECALL STRATEGY
3.1. Nature of communication (phone, fax, telegraphs,
letters, news papers, etc.)
__________________________________________________
__________________________________________________
Depth of recall: (Wholesalers, retailers, general public)
__________________________________________________
34

 The GM, QA/QC Regulatory or GM

manufacturing implements recall without delay.
They also prepare an interim reconciliation
report after 30 days and submit a copy to
concerned authorities.
After that prepares a final reconciliation report
after 90 days and submits a copy for
verification of the success of recall.

35

 Signature of GM, QA/QC Regulatory G.M.

manufacturing
should be taken.
Steps should betaken to prevent the re-occurrence.
Prior to completion of recall the following points
should be considered:
Method of destruction of the product .
A designed area to receive returned medicines.
Inventory of medicine.
Destruction authorization.
The recall will be terminated when the GM, QA/QC
Regulatory or GM manufacturing are assured that
recall has been completed reasonably and a
medicine record status report is completed.
36

INDIAN PHARMACEUTICALS LIMITED

MEDICINE RECALL OR WITHDRAWAL, PROCEDURE STATUS
REPORT
Date: ________ product: ___________ Strength:____________
Pack size: ____________ B.no: _________Exp.date: ________
Nature of defect: ____________________________________
Reason for recall: _____________________________________
Indication of health risk or any other reason: ________________
Reported clinical problems: ______________________________
Method of communication to users:
Method
Action
Date
Target Group
Number

Phone

Letter

Telegram

TV

Radio, Press etc.

37

 GM, QA/QC Regulatory or GM manufacturing shall

prepare a Standardized recall letter and
press statement.
INDIAN PHARMACEUTICALS LIMITED
STANDARD RECALL LETTER
Dear customer:
It has come to our notice (product name)
_______________ having batch number ______________ or
has shown ________ please refrain from prescribing or
dispensing any of this batch number and return all your
stock of this batch number to our office at:
__________________________________________
All returned stock or this batch number will be replaced
as free of charge. We apologies for any inconvenience
caused to you and thank you for your co-operation.
Yours faithfully,
G.M. QA/QC Regulatory
38

 After the authorization by GM, QA/QC Regulatory or GM

manufacturing, the recalled material along with stock in
hand shall be destroyed and that should be recorded.
RECALL CLASSIFICATION:
FDA classified the product recall depending on the health
hazard caused by the product .
(1)Class I is a situation in which there is a reasonable
probability that the use of, or exposure to, a violative
product will cause serious adverse health consequences
or death.
(2)Class II is a situation in which use of, or exposure to, a
violative product may cause temporary or medically
reversible adverse health consequences.
(3)Class III is a situation in which use of, or exposure to, a
violative product is not likely to cause adverse health
consequences.
39

RECALL POLICY:
Recall is an effective method of removing or
correcting consumer products that are in
violation of laws administered by the FDA.
Recall may be undertaken voluntarily and at
any time by manufacturers and distributors,
or at the request of FDA.
Recall is generally more appropriate and
affords better protection for consumers.
Seizure, multiple seizure, or other court action
is indicated when a firm refuses to undertake
a recall requested by the Food and Drug
Administration.
40

HEALTH HAZARD EVALUATION:

An evaluation of the health hazard presented by a
product being recalled or considered for recall will be
conducted by an ad hoc committee of Food and Drug
Administration.
It involves the assessment of hazards to various
segments of the population, degree of seriousness,
likelihood of occurrence, consequences etc.
RECALL TEAM:
A recall coordinator is to be appointed and members of a
recall team identified from the various functional areas.
All members must ensure that all procedures are carried
out effectively and efficiently. The team should receive
appropriate training.
The Recall Management Team list shall be updated at
least four times a year.
41

NAME

Chief
Executive
Officer

ALTERNATE
PERSON

Production
Manager

BUSINESS
PHONE

AFTER HOURS
PHONE

RESPONSIBILITIE
S DURING
RECALL

Quality
Assurance
Manager

Production
Manager

Decision
Making
Media
Communicat
ion
Contacting
Accounts
CFIA,/
Health
Department
s Contact
Obtaining
Legal
Counsel
Quality
Assurance /
Technical
Advisory
Complaint
Investigation
CFIA /
Health
Department
s Contact
42

RECALL STRATEGY:
(1)A recall strategy that takes into account the
following factors :
(i) Results of health hazard evaluation.
(ii) Ease in identifying the product.
(iii) Degree to which the product's deficiency is
obvious to the consumer or user.
(iv) Degree to which the product remains unused
in the market-place.
(v) Continued availability of essential products.

43

 Elements of a recall strategy:

Depth of recall.
Public warning.
Effectiveness checks:
Level A--100 percent of the total number of
consignees to be contacted.
Level B- greater that 10 percent and less than 100
percent of the total number of consignees.
Level C--10 percent of the total number of
consignees to be contacted.
Level D--2 percent of the total number of
consignees to be contacted.
Level E--No effectiveness checks.
44

 TERMINATION OF RECALL:
A recall will be terminated when the FDA
is confident that product has been
removed from market in accordance with
recall strategy. FDAs written notice to the
regulatee is the real termination.

45

PRODUCT RECALL CHART

Contd .
46

47

References
1.Us48 Food &drug administration.21 code of
federal regulation-part 211.198.
2. Current good manufacturing practices of
pharmaceuticals - Manohar . A . Potdar.
3. How to practice GMP By P.P. Sharma
4. Validation in pharmaceutical industry by P.P.
Sharma.
5. Recall Manual
(http://www.google.co.in/#sclient=psy&hl=en&source=hp&q=R
ECALL+MANUAL&pbx=1&oq=RECALL+MANUAL&aq=f&aqi=g2
g-v2gm1&aql=&gs_sm=e&gs_upl=30014l34331l0l35759l13l12l0l0l0l
0l1466l12191l64.7l11l0&bav=on.2,or.r_gc.r_pw.&fp=259c071b4fb78fb5&biw=
1358&bih=566)

48

References
6. Complaint Handling in Pharmaceutical
Companies
Glaucia Karime Braga*; Faculty of
Pharmaceutical Sciences, University of Sao
Paulo, Brazil.
7. WHO technical reports series, No. 908, 2011.
8. Good Manufacturing Practices for
pharmaceuticals A Plan for total Quality
control from manufacture to consumer 5th
edition - Sidney H. Willig.
9. www.interscience.com
10. www.google .com
11.www.photobucket.com

49

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